Kornimate/medical-research-clean huggingface dataset:
four-week breathing interventions on gut symptoms, heart rate variability, and psychological measures in runners

Conditions: Gastrointestinal System--Abnormalities; Anxiety; Visceral Pain

Summary: recent research has suggested that stress and anxiety levels are associated with gastrointestinal (gi) symptoms in endurance athletes (runners, cyclists, triathletes). yet, there has been limited attempt to evaluate whether gi symptoms during running can be mitigated by interventions designed to reduce stress and anxiety. thus, this study will evaluate the effects of four-week slow deep breathing and mindful breath counting interventions on subjective and objective measures of stress/anxiety and gi symptoms in runners with mild-to-high anxiety and that are prone to gi symptoms during runs.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * run at least 15 miles per week * access to internet * access to a smart phone that is compatible with ios or android applications * score at least a 5 on the gad-7 * report to have experienced gi symptoms "sometimes", "often" or "always" during runs in the previous month. * if on a psychotropic medication, must be on a stable dose for the past 3 months. * live within the contiguous united states exclusion criteria: * younger than 18 years * run less than 15 miles per week * do not have access to the internet * do not have access to a smart phone that is compatible with ios or android applications * score less than 5 on the gad-7 * report to have "never" or "rarely" experienced gi symptoms during runs in the previous month * are being prescribed a psychotropic medication and have not had a stable dose for at least three months. * do not live within the contiguous united states
early prediction of sepsis

Conditions: Sepsis

Summary: in this clinical trial a novel medical device software will be validated prospectively. the software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at intensive care units.


Eligibility criteria:
inclusion criteria: 1. adult patient (age ≥18 years). 2. patient is admitted to the icu during the recruitment period of the trial. exclusion criteria: 1. patient is participating in another interventional clinical trial which, as judged by the investigator, could potentially impact variables used by the sepsis prediction algorithm or has participated in such interventional clinical trial within the last 30 days. 2. patient is known to be pregnant. 3. death is deemed imminent and inevitable, at the investigator's discretion. 4. patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision 5. patient has previously been enrolled in this trial.

Keywords: prediction
exercise intervention in patients with metabolic syndrome and renal disease: a prospective study

Conditions: Metabolic Syndrome; CKD

Summary: introduction: obesity (ob) and metabolic syndrome (mets) are risk and progression factors for chronic kidney disease (ckd). however, the effect of ob/mets intervention with exercise on renal function progression and proteinuria is unknown. objective: to analyse the effect of therapeutic exercise on mets and main renal outcomes in patients with ckd. methodology: this is a 6-month prospective exploratory study. patients with stablished ckd (1-4) and mets were treated with individualised incremental exercise (aerobic and resistance). simultaneously, a plan of adherence was set up to promote compliance. renal and metabolic outcomes were collected. the main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (gfr), measured by iohexol dbs, at 0, 3 and 6 months. at the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.


Eligibility criteria:
inclusion criteria: * age \>18 years * ckd of diverse aetiologies * estimated gfr ≥ 30 ml/min * bmi ≥ 27 kg/m2 associated to mets or diabetes mellitus (dm) * stable renal function for at least 6 months before screening * ability to perform exercise exclusion criteria: * clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced ckd, pulmonary hypertension, or limb amputations * inability to understand the protocol * severe psychiatric illness * allergy to iodine

Keywords: adherence chronic kidney disease metabolic syndrome obesity therapeutic exercise
phase 2a study of ar882 alone and in combination with febuxostat or allopurinol in gout patients

Conditions: Gout Patients

Summary: the study is designed to evaluate the pk/pd, safety and tolerability of ar882 alone or in combination with febuxostat or allopurinol when administered to gout patients.


Eligibility criteria:
key inclusion criteria: * history of gout * sua \> 7 mg/dl * estimated glomerular filtration rate (egfr) ≥ 60 ml/min/1.73m2 key exclusion criteria: * malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * history of cardiac abnormalities * active peptic ulcer disease or active liver disease * history of kidney stones * allergy or intolerance to colchicine, febuxostat, and allopurinol

Keywords: hyperuricemia gout urat1
brain-heart interaction in coronary plaque stability and cardiovascular events

Conditions: Coronary Artery Disease

Summary: the effect of brain-heart interaction remains unclear. the study aims to investigate the biological interconnection between brain neural activity and coronary plaque morphological and inflammatory features, as well as their connection with clinical outcomes.

brain neural activity assessed by resting amygdalar activity (amyga) can predict cardiovascular events. however, its biological interconnection with plaque vulnerability i is not fully understood. coronary computed tomographic angiography (ccta) is a non-invasive technique that enables comprehensive assessment of morphological characteristics of coronary atheroma and estimates the level of plaque instability. recently, perivascular fat attenuation index (fai) enables assessment of coronary inflammation by analyzing changes of perivascular adipose tissue attenuation in ccta. 18f-fluorodeoxyglucose-positron emission tomography/computed tomography (18f-fdg-pet/ct) enables simultaneous estimation of multi-system activities including brain neural activity and hematopoiesis. the present study aims to use ¹⁸f-fdg pet/ct to assess the amyga, and to investigate its association with ccta assessed plaque morphological and inflammatory features as well as their ability in predicting future cardiovascular disease events.

Eligibility criteria:
inclusion criteria: * 1) age: greater than 20 * 2) patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period; * 3) patients absence of acute or chronic inﬂammatory or autoimmune disease at the time of imaging; * 4) patients with ccta performed within 90 days of 18f-fdg pet/ct scan as part of routine clinical practice * 5) patients with diameter stenosis \>30% by ccta but without coronary revascularization exclusion criteria: * 1) complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc) * 2) coronary lesion with heavy calcification * 3) chronic renal insufficiency (serum creatinine \>2.0mg/dl) * 4) severe liver dysfunction (aspartate transaminase or alanine transferase \> 5 times of upper normal limit) * 5) pregnancy or potential pregnancy * 6) life expectancy less than 5 year
antiviral activity of entecavir in patients receiving liver transplant due to chronic hepatitis b virus infection

Conditions: Hepatitis B, Chronic

Summary: the purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis b virus (hbv) in participants who receive an orthotopic liver transplant (olt) due to hbv infection.


Eligibility criteria:
inclusion criteria: * patients receiving orthotopic liver transplant (olt) due to end-stage liver disease because of chronic hbv infection, with hbv-dna \< 172 iu/ml (approximately \< 1000 copies/ml) prior to liver transplant * must have detectable hepatitis b surface antigen (hbsag) at screening and for at least 24 weeks prior to screening exclusion criteria: * patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm * co-infection with human immunodeficiency virus (hiv), cytomegalovirus (cmv), epstein-barr virus (ebv) or hepatitis c virus (hcv)

Keywords: chronic hepatitis b virus, liver transplant
assistive device training in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with multiple sclerosis.

40 people with multiple sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. one group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. all participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. all participants will record their falls on falls calendars. participants in the training group will receive mri scans to assess neural connectivity at baseline and after completion of the training program. the purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by mri scans, is seen in those who participate in the training.

Eligibility criteria:
inclusion criteria: * multiple sclerosis of any type, * self-reported history of at least 1 fall in the previous year, * able to walk at least 25 feet with or without an assistive device, * clinically stable multiple sclerosis (no relapse in 30 days prior to enrollment), * intermittent or constant unilateral or bilateral assistance required to walk, * right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study. exclusion criteria: * serious psychiatric or medical conditions that would preclude reliable participation in the study, * dementia (mmse \<24), * deafness, * blindness, * inability to follow directions in english, * significant upper extremity tremor or weakness, * more than 1 hour of assistive device training within the previous 3 years, * any exclusions to receiving mri scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).

Keywords: mobility walking aids falls gait and balance
the effects of a jump rope exercise program on body composition and self-efficacy in obese adolescent girls

Conditions: Prehypertension; Blood Pressure; Abdominal Obesity; Self Efficacy; Adiposity; Insulin Sensitivity

Summary: the purpose of this study was to examine the impact of a 12-week jump rope exercise program on body composition, blood pressure, insulin resistance, and academic self-efficacy in prehypertensive adolescent obese girls. forty-eight prehypertensive adolescent obese girls participated in this study. the girls were randomly divided into the jump rope exercise intervention group (ex, n=24) and control group (con, n=24). the ex group performed a jump rope training program at 40-70% of their heart rate reserve (hrr) 5 days/week for 12 weeks (sessions 50 minutes in duration). the con group did not participate in any structure or unstructured exercise protocol. blood pressure, body fat percentage, waist circumference, blood glucose and insulin, homeostatic model assessment - insulin resistance, and academic self-efficacy were measured before and after the 12-weeks study.


Eligibility criteria:
inclusion criteria: * prehypertensive * sedentary (no regular exercise training or physical activity within the last year) * no weight loss diet during the last six months * obese exclusion criteria: * pregnancy * chronic disease * daily medication use

Keywords: adolescence exercise body composition insulin sensitivity obesity academic self-efficacy
diasport - endurance-orientated training program with children and adolescents on maintenance hemodialysis

Conditions: End Stage Renal Failure on Dialysis

Summary: physical activity is considered essential for optimal health, development, socialization and well-being of children. however patients with end-stage renal disease (esrd) are often restricted from participation in exercise activities. this is especially true for children on hemodialysis (hd). as a consequence their exercise capacity is reduced, both before, but most impressively after hd. in a nationwide randomized, multi-center design this study aims to proof the influence of an individualised endurance training program by bicycle ergometer performed during dialysis on the efficacy of hd, measured as single pool kt/v. secondary goals are to enhance physical performance, physical and mental well-being, and to improve measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). a positive impact of physical activity was observed in adults on hd, although most studies did not address this issue in a randomised protocol. despite this beneficial evidence in adults, sport is still not integrated as part of standard care in patients on maintenance hd. the study protocol, developed in close collaboration with the german sport university cologne, differs substantially from previously published reports as it uses bicycle ergometer training in an upright position outside the dialysis couch and adapts the intensity of intervention to the patient's capabilities. based on the expected results the investigators will develop an individualised training program to be integrated in the standard care of (pediatric) patients on maintenance hd.


Eligibility criteria:
inclusion criteria: * end stage renal disease with need of renal replacement therapy * children and adolescents aged ≥6 to ≤19 years * maintenance hemodialysis for at least 3 months * stable and appropriate dialysis condition in the last 4 weeks before inclusion to the study (basically stable blood and dialysate flow rate and same dialyser) * single pool kt/v according to dialysestandard 2006 \> 1.2 * informed consent exclusion criteria: * participation in another interventional clinical trial * severe primary neurologic, orthopaedic or cardiac disease, or secondary disease known as a contraindication for endurance training * uncontrolled hyper- or hypotension, or cardiac disease * recurrent uncontrolled epileptic seizures * dialysis shunt at the lower limbs * pregnancy * already planned medical intervention, for example living donor kidney transplantation or any other surgery, within the first period of the trial which will cause cancelation of more then 3 training units in a row * subjects who are in dependency to the sponsor or the pi of the trial, or confined to an institution on judicial or official behalf

Keywords: hemodialysis dialysis efficacy cardiorespiratory capacity exercise capacity children and adolescents
"nanotechnologies applied to general surgery and emergency surgery: buckypaper as a new fixing method for prosthetic materials for the treatment of hernia and incisional hernia in laparotomy and laparoscopic

Conditions: Hernia; Incisional Hernia

Summary: "nanotechnologies applied to general surgery and emergency surgery: the buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". experimentation on breed pig lantrace animal model.


Eligibility criteria:
inclusion criteria: * animal model: lantrace female pigs of 20 kg of body weight exclusion criteria: * any kind of illness in porcine subjects

Keywords: hernia incisional hernia device pig
lotcol study: local treatment of colo-rectal liver met

Conditions: Metastatic Colo-rectal Cancer

Summary: in this study the investigators will include colo-rectal cancer (crc) patients starting last line of standard palliative chemotherapy. eligible patients include patients with kras mutation starting line or kras wild type starting line treatment. standard treatment today for these patients is chemotherapy only and median overall survival (os) is about 10 months. the hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. the investigators experience with local treatment of liver metastases in crc patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma of colon or rectum * ambulatory with an ecog performance status 0-2 * at least 18 years of age * non-resectable liver metastases * progressive disease on or within 4 months after 1.line chemotherapy for kras mutant or after 2.line chemotherapy in kras wild type patients * 1-4 liver metastases with largest diameter of up to 6 cm on ct-scan * up to 20 lesions in liver with no more than 4 lesions larger than 4 cm * the patients will start 2./3. line chemotherapy (kras mutant/kras wt) * laboratory values as the following: * anc ³ 1.5 x 109/l * platelets ³ 100 x 109/l * hb ³ 9g/dl * creatinine £ 2x upper limit of normal * bilirubin \< 2.0x the upper limit of normal * asat and alat £ 5x the upper limit of normal * albumin levels \> 30 g/l * inr\<1.3 * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ich gcp, and national/local regulations exclusion criteria: * previous treatment with 2. or 3. line chemotherapy (kras mutant/kras wt) * history of prior metastatic disease the last 3 years * history of cns or bone metastases * significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia * largest liver mets \>6 cm, more than 4 liver lesions \>4 cm * pulmonary mets\>3 cm * lymph node mets \>2.5 cm * chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment * any reason why, in the opinion of the investigator, the patient should not participate.
impact of mothers touch program to improve maternal health after birth

Conditions: Post Partum Depression; Quality of Life

Summary: after the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. that all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems. 'sava mahina (6-week period) is a traditional practice for postpartum women in india, which include special diet, lifestyle and supportive care. the current multicenter randomized controlled trial (rct) aims to evaluate outcomes of indian postpartum care on women.


Eligibility criteria:
inclusion criteria: * primigravida * healthy pregnancy * consent to participate exclusion criteria: * mental health diagnosis * severe depression or psychosis * substance abuse
utility of the administration of chesnut and quebracho extract for irritable bowel syndrome diarrhea predominant

Conditions: Irritable Bowel Syndrome; Diarrhea

Summary: irritable bowel syndrome is a highly prevalent disorder and consumes many health resources. its physiopathogenesis is multifactorial. some of the factors involved have to do with the alteration of the intestinal microbiota, low-grade inflammation and the alteration of intestinal permeability. specific tannins have been shown to have prebiotic effects and could be useful in treating this condition. this is an exploratory before-after study that aims to evaluate the effect of a chestnut and quebracho extract on the symptoms of ibs diarrhea predominant, serum cytokine levels, microbiota and intestinal permeability, as well as on metabolomics.

in vitro studies have shown that chestnut and quebracho extract has a prebiotic effect of modulating the intestinal microbiota, but also, bacterial fermentation produces metabolites with powerful anti-inflammatory effects such as quecetin. irritable bowel syndrome (ibs) is a multifactorial disorder involving factors related to the intestinal microbiota, low-grade inflammation, and impaired intestinal permeability. in this study, 30 patients with predominant ibs diarrhea and 50 healthy controls will be included. ibs patients will receive chestnut and quebracho extract twice a day for 8 weeks. they will be measured at baseline and at 8 weeks: 27 serum pro and anti-inflammatory cytokines and serum zonulin. likewise, the intestinal microbiota and metabolomics will be evaluated.

Eligibility criteria:
inclusion criteria: * ibs patients: both sexes with a diagnosis of irritable bowel syndrome variety diarrhea according to the rome iv criteria healthy controls: relatives of patients who do not show any disease, who do not take medication or present symptoms. exclusion criteria: * patients with digestive tract disease, * systemic diseases such as severe heart, kidney or liver failure, * history of previously known digestive tract surgeries and / or intestinal adhesions, * diabetes mellitus, * cirrhosis, * inflammatory bowel disease, * celiac disease, * patients with cognitive impairment, * alcoholics, * lack of consent . * patients who have received antibiotics in the last month.

Keywords: intestinal microbiota intestinal permeability intestinal inflammation